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Pantoprazole and Docetaxel for Men With Metastatic Castration-Resistant Prostate Cancer - a Single Arm Phase II Clinical Trial With a Predefined Reference Group (PANDORA)


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Pantoprazole and Docetaxel for Men With Metastatic Castration-Resistant Prostate Cancer - a Single Arm Phase II Clinical Trial With a Predefined Reference Group (PANDORA)


Inclusion Criteria:



- Age ≥18yrs

- ECOG performance status ≤2

- Histologically or cytologically confirmed adenocarcinoma of the prostate

- Clinical or radiological evidence of metastatic disease

- Disease progression while receiving androgen deprivation therapy with an increase in
PSA of 25% or greater over nadir value measured on 3 consecutive occasions at least 1
week apart

- Antiandrogen therapy must have been stopped at least 4 weeks prior to start of trial
treatment (6 weeks in the case of bicalutamide or nilutamide)if there was a reduction
in serum PSA after this therapy was initiated

- Baseline serum prostate-specific antigen (PSA)≥10ng/ml

- Total testosterone <50 ng/dL (<1.7 nmol/L)

- Adequate hematologic values: neutrophil count ≥1,500/mm3, platelet ≥100,000/mm3,
hemoglobin ≥10.0 g/dl

- Adequate hepatic and renal function: total bilirubin level ≤1.5 x ULN (unless
secondary to documented Gilbert's disease); ALT,AST, and creatinine ≤1.5 x ULN

- Ability to understand and to sign consent for the study

Exclusion Criteria:

- Prior treatment for prostate cancer with chemotherapy or radioisotopes

- History of another cancer within the preceding five years (except basal or
squamous-cell skin cancer or adequately treated superficial bladder cancer)

- Known or suspected brain or leptomeningeal metastases

- Symptomatic peripheral neuropathy of grade 2 or higher

- Major surgery within 4 weeks of start of trial treatment

- Radiotherapy to ≥25% of the bone marrow and any radiotherapy within 4 weeks of start
of trial treatment

- Known hypersensitivity to trial treatment or hypersensitivity to any of its
components

- Any concomitant drugs contraindicated for use with the trial treatment

- Any serious underlying medical condition which could impair the ability of the
patient to participate in the trial

- Any psychological, familial, sociological or other patient related factors that might
preclude compliance with the study protocol

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Confirmed PSA response

Outcome Description:

The primary endpoint is met if PSA falls to ≤50% of baseline, maintained for ≥3 weeks.

Outcome Time Frame:

20 months

Safety Issue:

No

Authority:

Canada: Health Canada

Study ID:

PANDORA

NCT ID:

NCT01748500

Start Date:

January 2013

Completion Date:

August 2014

Related Keywords:

  • Prostate Cancer
  • metastatic
  • Prostatic Neoplasms

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